TRANSPARENT FILM I.V. SITE/WOUND DRESSING— 510(k) K896421

Name: FDA 510(k) clearance K896421
Creator: U.S. Food and Drug Administration
Published: 1990-01-31

Substantially Equivalent

Catalina Biomedical Corp.

FDA 510(k) clearance K896421 for TRANSPARENT FILM I.V. SITE/WOUND DRESSING, Substantially Equivalent on 1990-01-31. Applicant: Catalina Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Catalina Biomedical Corp.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1989-11-08
Decision date: 1990-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duarte, CA, US

Download summary PDF View on FDA.gov ↗

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K981860 — A P HARNESS1999-06-03
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

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K920050 — BIOLEX WOUND GEL,1992-04-07
K913480 — WOUND CARE TRAY A1991-10-18
K913479 — WOUND CARE TRAY B1991-10-08
K896358 — VARI/MOIST WOUND DRESSING1990-02-01

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.